On November 4, 2025 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system indications, reported the receipt of written minutes from a Type B pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the planned Phase 3 program for NDV-01 in non-muscle invasive bladder cancer (NMIBC) patients. The Company will be requesting follow-up meetings with FDA to discuss each development path. Relmada secured FDA alignment on certain key elements of the planned Phase 3 pivotal program for NDV-01, expected to begin in H1 2026 and incorporating two independent studies for approval in two separate indications:
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High-grade, 2nd line BCG-unresponsive NMIBC patients
Intermediate risk NMIBC in the adjuvant setting
Key Outcomes from the FDA Type B pre-IND meeting (specific study design details to be further discussed with the agency):
In high-grade, 2nd line BCG-unresponsive setting, the FDA stated that a single arm trial might be acceptable in a more refractory patient population.
In the intermediate risk NMIBC setting, the FDA agreed that a proposal to randomize patients post-TURBT to adjuvant NDV-01 vs observation, evaluating a time-to-event endpoint, is generally acceptable.
Further non-clinical studies are not required. FDA indicated that no further non-clinical studies are required to support a 505(b)(2) New Drug Application (NDA).
"The positive outcome of our Type B meeting and alignment with the FDA on the Phase 3 pivotal program mark a key milestone for Relmada and NDV-01," said Raj Pruthi, MD, Chief Medical Officer – Urology, Relmada Therapeutics. "We believe the FDA’s guidance provides a path to advance NDV-01 for patients with NMIBC who currently have limited options. We believe a single-arm registrational study in high-grade, refractory BCG-unresponsive patients offers a rapid route to potential approval, while alignment on a separate second pivotal study in intermediate-risk NMIBC could enable an additional indication and broader clinical adoption."
Sergio Traversa, Chief Executive Officer of Relmada Therapeutics, stated: "We added NDV-01 to our portfolio based on its strong potential to transform the treatment of NMIBC. The outcome of our Type B meeting with the FDA further reinforces our confidence in the path forward and in NDV-01’s potential to become a best-in-class, durable, ready and easy-to-use, in-office, bladder-sparing therapy. We look forward to initiating the Phase 3 programs in the first half of 2026."
Also, Relmada announced 9-month follow-up data from the Phase 2 study of NDV-01 in non-muscle invasive bladder cancer.
Highlights of the 9-month follow-up data and updated 3-month and 6-month data from the Phase 2 study of NDV-01:
Clinical Results (Response Data)
Complete Response % (n/N)
Anytime 92% (23/25)
3 months 84% (21/25)
6 months 87% (20/23)*
9 months 85% (17/20)*
*Includes patients with CR after re-induction. 60% CR rate after re-induction.
Two subjects have reached 12-month assessment, and both have a CR
No patient had progression to muscle invasive disease
No patient underwent a radical cystectomy
No new safety signals in terms of type, number, or degree of AEs — with no patients having a >= Grade 3 TRAE and no patients discontinued treatment due to AEs
36 enrolled patients (receiving >= 1 dose), of which 22 (61%) experienced a treatment-related AE. Among treatment-related AEs, 62% were transient uncomfortable urination (dysuria), 9% were asymptomatic positive urine culture and 7% were hematuria.
Efficacy in BCG-Unresponsive Subpopulation**:
Clinical Results (Response Data)
Complete Response % (n/N)
Anytime 91% (10/11)
3 months 82% (9/11)
6 months 78% (7/9)
9 months 88% (7/8)
n = 18 patients dosed in BCG-UR subpopulation
BCG-UR defined by FDA definition**
BCG-UR, Bacillus Calmette-Guérin (BCG) – Unresponsive
About NDV-01
NDV-01 is a sustained-release, intravesical formulation of gemcitabine and docetaxel (Gem/Doce), in development for the treatment of non-muscle invasive bladder cancer. It is designed to enable Gem/Doce bladder retention and gradual drug release over 10 days. The formulation creates a soft matrix that enhances local tumor exposure. NDV-01 is ready to use, convenient to administer in-office in less than 10 minutes, and does not require preparation, anesthesia or specialized equipment.
About NMIBC
NMIBC represents 75-80% of all bladder cancer cases and is associated with high recurrence (50 –80% over 5 years). With over 744,000 prevalent cases in the U.S. and limited treatment options, the market opportunity is significant. NDV-01 has the potential to serve as a frontline or salvage therapy and could be applicable across multiple NMIBC subtypes.
(Press release, Relmada Therapeutics, NOV 4, 2025, View Source [SID1234661915])